Skip to main content
OpenTrials
Completed

NCT Number: NCT06959264

Effect of Virtual Reality Goggles on Anxiety, Comfort and Complications in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy

This study was aimed to determine the effect of virtual reality goggles on anxiety, comfort and complication development in patients undergoing transrectal ultrasound-guided prostate biopsy in a randomized controlled experimental study. The study will be conducted with individuals who applied to the Department of Urology of Mersin University Hospital. The minimum sample calculation with 95% power was calculated as a total of 70, 35 in each group, in the G*Power (3.1) program. Introductory Information Form, State Anxiety Scale, Complication Follow-up Form and Visual Analog Scale will be used to collect the data. Introductory Information Form, State Anxiety Scale and Visual Analog Scale will be filled in the patients. After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule. Patients in the study group will be shown a video with virtual reality glasses during the procedure. Virtual reality goggles will be used to watch nature landscapes with relaxing music background, adjusted at the level of volume desired by the patient. Virtual reality goggles will be applied during the procedure. The control group will not receive any intervention. After the virtual reality application, anxiety levels and comfort levels will be re-evaluated after the procedure. The patients will be called by the researchers after 24 hours and the Complication Follow-up Form will be filled out. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University

Mersin, 33400, Turkey (Türkiye)

About this study

This study was aimed to determine the effect of virtual reality goggles on anxiety, comfort and complication development in patients undergoing transrectal ultrasound-guided prostate biopsy in a randomized controlled experimental study. The study will be conducted with individuals who applied to the Department of Urology of Mersin University Hospital between May 2025 and May 2026 and met the sampling criteria. Taking the effect size 0.87 as a reference, d=0.87, (1- α, bidirectional), the minimum sample calculation with 95% power was calculated as a total of 70, 35 in each group, in the G*Power (3.1) program. Introductory Information Form, State Anxiety Scale, Complication Follow-up Form and Visual Analog Scale will be used to collect the data. Introductory Information Form, State Anxiety Scale and Visual Analog Scale will be filled in the patients. After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule. Patients in the study group will be shown a video with virtual reality glasses during the procedure. Patients will be asked to wear a virtual reality goggles (VR Shinecon G12 3d Virtual Reality Goggles Black 4.5-7.0 Inch) compatible with a mobile phone (Xiaomi Redmi Note 8 Pro 2019 model) with android operating system and minimizing sound loss in the supine position.Virtual reality goggles will be used to watch nature landscapes with relaxing music background, adjusted at the level of volume desired by the patient. Virtual reality goggles will be applied during the procedure. The control group will not receive any intervention. After the virtual reality application, anxiety levels and comfort levels will be re-evaluated after the procedure. The patients will be called by the researchers after 24 hours and the Complication Follow-up Form will be filled out. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Who agreed to participate in the study,
  • Patients over 18 years of age
  • Conscious, oriented and cooperative,
  • No communication problems,
  • Transrectal ultrasound guided prostate biopsy procedure,
  • No physical problems that would prevent the application of virtual reality goggles,
  • No previous experience with virtual reality glasses,
  • Undiagnosed anxiety,
  • No medication for anxiety
  • Patients without mental disorders

Exclusion criteria

  • Who did not agree to participate in the study,
  • Patients under 18 years of age,
  • Conscious, oriented and uncooperative,
  • Communication problems,
  • No transrectal ultrasound-guided prostate biopsy procedure,
  • With a physical problem that would prevent the application of virtual reality goggles,
  • Diagnosed with anxiety,
  • Taking medication for anxiety (anxiolytics, antidepressants, antipsychotics, etc.),
  • Patients with mental disorders

Treatment and study plan

Virtual Reality

Other

Patients in the study group will be shown a video with virtual reality glasses during the procedure. Patients will be asked to wear a virtual reality goggles (VR Shinecon G12 3d Virtual Reality Goggles Black 4.5-7.0 Inch) compatible with a mobile phone (Xiaomi Redmi Note 8 Pro 2019 model) with android operating system in supine position and minimizing sound loss. With the virtual reality goggles, nature landscapes with a relaxing music background will be watched by adjusting the volume at the level desired by the patient. Virtual reality goggles will be applied during the urodynamic procedure.

Primary outcomes

  1. Anxiety

    Time frame: 6 months

    The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.

  2. Comfort

    Time frame: 6 months

    Visual Analog Scale: It is a scale that provides a subjective assessment of comfort on a horizontal or vertical line from 0 -10 to evaluate the level of comfort.

  3. Complications

    Time frame: 6 months

    Patients will be questioned about bleeding in the first urine, hematuria, hematospermia, rectal bleeding, anal pain, dysuria and urinary retention within 24 hours after the procedure and recorded on the form.

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Collaborators

  • Mersin University

Registry information

Official study title

Effect of Virtual Reality Goggles on Anxiety, Comfort and Complications in Patients Undergoing Transrectal Ultrasound-guided Prostate Biopsy: A Randomised Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.